Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
3 participants
OBSERVATIONAL
2019-03-11
2021-07-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The evaluation of the total fat mass and in particular of its abdominal distribution (visceral adiposity) is important because an excessive adiposity generates adverse effects on the health (hypertension, dyslipidemia, cardiovascular risk and resistance to the insulin).
In addition, data on changes in body composition and bone mineral density were not available under a new psA treatment, namely ustekinumab (anti-IL12 / 23 antibody).
It is proposed to conduct a pilot study to evaluate body composition, distribution (visceral adiposity) and bone mineral density in patients with psoriatic arthritis (versus control subjects) and their changes after 6 months of treatment with ustekinumab
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Study of Classification and Activity Assessment of Psoriatic Arthritis Based on Power Doppler (PD) Ultrasonography (PDUS)
NCT06730334
Ultrasound Enthesitis Response in Psoriatic Arthritis
NCT03955861
Scintigraphy for Prediction In Rheumatoid Intentional Therapy Tapering
NCT05983848
Observational Real-world Evaluation of Cost of Infections of Rheumatoid Arthritis (RA) Patients on Biologics
NCT01166620
Information and Acceptability of Biosimilars
NCT04321291
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Psoriatic arthritis
Bone mineral density (BMD)
The bone mineral density (BMD) performed by DXA, which will allow the analysis of bone density (mg / cm²) at the lumbar spine (BMD L1 to L4) and the total hip (non-dominant).
This examination will also allow an analysis of the body composition at the same time (lean mass, fat mass and bone mass for the whole body).
Healthy volunteers
Bone mineral density (BMD)
The bone mineral density (BMD) performed by DXA, which will allow the analysis of bone density (mg / cm²) at the lumbar spine (BMD L1 to L4) and the total hip (non-dominant).
This examination will also allow an analysis of the body composition at the same time (lean mass, fat mass and bone mass for the whole body).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bone mineral density (BMD)
The bone mineral density (BMD) performed by DXA, which will allow the analysis of bone density (mg / cm²) at the lumbar spine (BMD L1 to L4) and the total hip (non-dominant).
This examination will also allow an analysis of the body composition at the same time (lean mass, fat mass and bone mass for the whole body).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Men and women ≥ 18 years
2. Patients with PsA according to CASPAR criteria,
3. Patients who do not have yet started ustekinumab,
4. Patients who signed the informed consent.
* Healthy volunteers:
1. Men and women ≥ 18 years
2. Patients who signed the informed consent.
Exclusion Criteria
1. History of fragility fracture AND / OR T-score ≤-3 if ≥50 years AND / OR Z-score ≤-3 if \<50 years during the screening phase,
2. Corticosteroids ≥10 mg / day,
3. Diseases or treatments affecting bone metabolism (breast cancer with anti-aromatase, malabsorption, primary hyperparathyroidism, uncontrolled hyperthyroidism ...),
4. History of radiotherapy on the lumbar spine or hip,
5. Patients undergoing hormone replacement therapy (HRT) or patients already on anti-osteoporotic therapy (bisphosphonates, strontium ranelate, teriparatide or denosumab),
6. Chronic kidney disease with creatinine clearance (CKD-EPI) ≤ 30 ml / min,
7. Weight\> 160 kg,
8. Patients under restrictive diet or considering a diet of this type during the study period,
9. Patients who have an intense exercise program or plan to benefit from it during the study period,
10. Pregnant or lactating women or having a pregnancy project,
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Pharmaceuticals
INDUSTRY
University Hospital, Lille
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julien Paccou, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Roger Salengro, CHU
Lille, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-A01552-53
Identifier Type: OTHER
Identifier Source: secondary_id
2017_39
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.